When the US Food and Drug Administration (FDA) announced this July that it would be pushing back a deadline requiring its approval for many e-cigarette and vaping products, the industry heaved a collective sigh of relief.

On July 28, FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

According to a press release on this matter, a key piece of FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes,” said FDA commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.

“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of FDA’s strategy,” said Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”

In its announcement, the agency also confirmed its commitment to “encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.”

To do so, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of August 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive.

Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, would be submitted by August 8, 2021, and applications for non-combustible products such as electronic nicotine delivery systems (ENDS) or e-cigarettes would be submitted by August 8, 2022. Additionally, FDA expects that manufacturers would continue to market products while the agency reviews product applications.

Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors.

To complement these larger policy considerations, FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, FDA intends to issue regulations outlining what information the agency expects to be included in premarket tobacco applications (PMTAs), modified risk tobacco product (MRTP) applications, and reports to demonstrate substantial equivalence (SE). FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars, and guidance documents.

FDA’s new stance has already received flak from some US Congress members, who accused Gottlieb of giving e-cigarettes and vaping a “free pass”, simply because of the delayed timeline for applications. Industry insiders, however, have welcomed this news, especially smaller businesses who, had FDA’s deeming rule – which required e-cigarettes to go through a lengthy and costly pre-market approval process before they could be sold on the market – gone through, could have easily gone out of business.

FDA’s change of heart hopefully will also influence legislators in countries around the world to follow. Presently, an increasing number of countries have been regulating e-cigarettes. More than a dozen countries and territories have even imposed a blanket ban on e-cigarettes, such as Brunei, Taiwan, Thailand, Singapore, Vietnam, Qatar, Oman, Jordan, UAE, Brazil, Argentina, Uruguay, Venezuela, and Norway. In the US, UK, and most other European countries, they can be legally sold to anyone over the age of 18.

FDA’s extended timelines will allow time for more scientific research on the effects of vaping and e-cigarettes to be conducted, providing a more thorough and accurate understanding on the topic. At the moment the topic of the effect of e-cigarettes is a raging debate full of conflicting research reports and controversy and accusations of hidden agendas by tobacco companies, e-cigarette companies, and the health sector. Perhaps, with five more years to work with, all sectors involved will finally be able to sort through these issues.